Yale Researchers Pose Troubling Questions About Early Essure Trials

Yale Researchers Pose Troubling Questions About Early Essure Trials

In September of 2015, the Food and Drug Administration decided to reconvene its Obstetrics and Gynecology Devices Panel, gathering together 19 women’s health experts to discuss the safety and efficacy of Essure, a controversial medical device for female sterilization.

This is not unfamiliar work to the FDA. The agency’s primary function, after all, is to review medical evidence and determine whether health products work as they should, while presenting as few side effects as possible. But there was something odd about this particular meeting: the device under discussion, a pair of metal implants inserted in a woman’s Fallopian tubes, had been approved nearly 13 years earlier.

Early Studies “Inadequate,” Experts Say

During the intervening years, significant questions about Essure’s safety had been raised, along with concerns about how stringently the device had been vetted prior to its approval.

In fact, the FDA approved Essure based on only two studies, and as an editorial in the New England Journal of Medicine (JAMA) recently pointed out, both studies were severely “limited” in their scope. A total of 926 women enrolled in the studies, which found that Essure was “reliable” (ie prevented pregnancy) in 97% of women. But hundreds of patients weren’t included in the final results. The studies’ conclusions, which served as a resounding success for then-manufacturer Conceptus Inc., were based only on 664 participants. So where did those 262 other women go?

Some ultimately chose not to undergo the procedure. Others failed to meet the screening requirements set by study administrators. But many were excluded from them, including women in whom the implantation procedure failed and those who did not undergo the check-up procedure (called a “hysterosalpingogram”) conducted 3 months after implantation. Women who showed up for that appointment, but in whom the implants had been placed incorrectly, weren’t followed, either.

Clinicians ultimately attempted the Essure procedure in 745 women, not altogether successfully in some cases. Only 632 of those patients, though, were followed for the next year to determine how effective the implants were at preventing pregnancy. Where safety was concerned, the study looked at only 682 of the women within the next year, slightly better, but still leaving out 63 patients. As time passed, the study became less and less comprehensive. By its second year, only 25% of the subjects were still being tracked.

Limitations & Long-Term Risks

All of this has raised serious concerns for many experts, including the Yale-affiliated gynecologists who authored the editorial in JAMA. For one, Essure is meant to be a permanent birth control option. “Permanent,” in this instance, means for a lifetime, but upon the device’s approval, “few women in the [preapproval] studies [had been] followed more than a year – a limitation that precludes conclusions about longer-term risks.”

Today, we have substantially more evidence of Essure’s long-term risks – and the data doesn’t look good. More than 5,000 side effect reports have been filed with the FDA so far, ranging from severe pain to flare-ups of possible nickel allergies (Essure implants contain nickel titanium).

The device’s efficacy numbers have also been called into question. Once thought to prevent pregnancy in up to 99.83% of women, the implants may actually result in pregnancy for up to 9.6% of women within ten years. Those results, found in a study conducted at the Yale School of Medicine, suggest a far less effective sterilization option than traditional methods. Tubal ligation, the most common procedure for female sterilization, is more than 99% effective. Over the course of ten years, tubal ligation’s efficacy decreases, but only to 98% in women between 28 and 33, and 95% in women under 28.

Side Effect Reports Censured, Participants Claim

Study participants like Kimberly Lira, who joined the original Essure clinical trial back in 2001, say they “consistently reported health issues associated with the device,” only to have their concerns downplayed. Lira told an Arizona ABC affiliate “she’s lived in nearly constant pain” since receiving the implants. 15 years later, she requested her medical records from the trial – and noticed some “questionable notations.” Where she’d reported “severe menstrual cramping,” “severe” had been physically crossed out, and beside her reports of “pelvic tenderness” and ” ‘a lot more’ unusual pain,” an administrator had described her comfort level as “excellent.”

Lira’s experience doesn’t seem to be an isolated incident. Kim Hudak, who came out against a different trial, one of two required by the FDA after Essure’s approval, says her own reports of severe pain were similarly mischaracterized. Despite reporting “four-hour episodes of lower back pain,” according to NBC New York, Hudak’s records consistently report her comfort with the device as – again – “excellent.” Hudak went further in her critique, noting that of five possible options for comfort level, four were positive. When patients were asked to characterize their response to Essure, the study gave them a choice between “excellent,” “very good,” “good,” “fair” and “poor.” That imbalance, Hudak says, led to a significant under-reporting of side effects.

Controversy has swirled around Essure for months, thanks in large part to the revelations of former trial subjects like Lira and Hudak.

The FDA, though, has been less forthcoming. Its expert panel, convened in September, gave Essure a virtual pass. While they suggested that additional data should be collected, the panel conceded that a new study “would be impractical […] at this point in time.” The FDA continues to review information gathered at the panel’s meeting, along with new side effect reports, but has yet to announce any regulatory actions.

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Michael Monheit, Esq. is an attorney with decades of experience in mass torts. Managing attorney at Pennsylvania's Monheit Law, he is proud to fight for the rights of patients harmed by potentially-dangerous medical devices.